Back to resultsEffects of Preoperative Immunonutrition in Patients Undergoing Hepatectomy
Primary Purpose
Bile Duct Cancer
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Oral IMPACT
Sponsored by
About this trial
This is an interventional prevention trial for Bile Duct Cancer focused on measuring immunonutrition, hepatectomy, Th1, Th2
Eligibility Criteria
Inclusion Criteria:
- hepatectomy
Exclusion Criteria:
- age younger than 18 years
- ongoing infection
- gastrointestinal obstruction
- respiratory dysfunction
- cardiac dysfunction
- hepatic dysfunction
- renal failure
- history of recent immunosuppressive or immunological disease
- preoperative evidence of widespread metastatic disease
Sites / Locations
- Chiba University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
group A
group B
Arm Description
preoperative immunonutrition
ordinary diet
Outcomes
Primary Outcome Measures
postoperative infectious complication
Secondary Outcome Measures
plasma IL-6, CRP, Th1/Th2 balance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01256047
Brief Title
Effects of Preoperative Immunonutrition in Patients Undergoing Hepatectomy
Official Title
Effects of Preoperative Immunonutrition on Infectious Complication and Th1/Th2 Differentiation in Patients Undergoing Hepatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chiba University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether preoperative immunonutrition is effective on infectious complication and Th1/Th2 differentiation in patients with major hepatectomy.
Detailed Description
The investigators reported that preoperative immunonutrition improve the incidence of postoperative infectious complication in patients after hepatectomy, and modulation of Th1/Th2 differentiation may play important roles in this effect.
Object of this study is to investigate the effects of preoperative immunonutrition on incidence of postoperative infectious complication, and Th1/Th2 balance after hepatectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bile Duct Cancer
Keywords
immunonutrition, hepatectomy, Th1, Th2
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Active Comparator
Arm Description
preoperative immunonutrition
Arm Title
group B
Arm Type
No Intervention
Arm Description
ordinary diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral IMPACT
Other Intervention Name(s)
Oral IMPACT; Ajinomoto Pharma Co., Ltd, Tokyo, Japan
Intervention Description
oral supplement for 5 days(1L/day) before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA
Primary Outcome Measure Information:
Title
postoperative infectious complication
Time Frame
30 days
Secondary Outcome Measure Information:
Title
plasma IL-6, CRP, Th1/Th2 balance
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
hepatectomy
Exclusion Criteria:
age younger than 18 years
ongoing infection
gastrointestinal obstruction
respiratory dysfunction
cardiac dysfunction
hepatic dysfunction
renal failure
history of recent immunosuppressive or immunological disease
preoperative evidence of widespread metastatic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katsunori Furukawa, MD
Organizational Affiliation
Chiba University
Official's Role
Study Director
Facility Information:
Facility Name
Chiba University
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
26965712
Citation
Uno H, Furukawa K, Suzuki D, Shimizu H, Ohtsuka M, Kato A, Yoshitomi H, Miyazaki M. Immunonutrition suppresses acute inflammatory responses through modulation of resolvin E1 in patients undergoing major hepatobiliary resection. Surgery. 2016 Jul;160(1):228-236. doi: 10.1016/j.surg.2016.01.019. Epub 2016 Mar 8.
Results Reference
derived
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Effects of Preoperative Immunonutrition in Patients Undergoing Hepatectomy
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